BD MULTITEST 6-COLOR TBNK REAGENT, MODEL 644611
FDA 510(k) clearance K090967 · decided 2009-07-31
Clearance details
- K-number
- K090967
- Device name
- BD MULTITEST 6-COLOR TBNK REAGENT, MODEL 644611
- Applicant
- Bd Biosciences
- Decision
- Substantially Equivalent
- Date received
- 2009-04-06
- Decision date
- 2009-07-31
- Days to decision
- 116 days
- Clearance type
- Traditional
- Product code
- GKZ
- Device class
- 2
- Regulation number
- 864.5220
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- San Jose, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| BD Trucount Tubes (Cat. No. 340334), used for determining absolute counts of leucocytes in recall (Z-0171-2023) | Becton, Dickinson and Company, BD Biosciences | 2022-11-03 |
| BD Trucount Tubes (Cat. No. 663028), used for determining absolute counts of leukocytes in recall (Z-0172-2023) | Becton, Dickinson and Company, BD Biosciences | 2022-11-03 |
| BD Multitest 6-Color TBNK with optional BD Trucount Tubes (Cat. No. 662995), for use with recall (Z-0173-2023) | Becton, Dickinson and Company, BD Biosciences | 2022-11-03 |